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Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement

This study has been terminated.
(Terminated due to limited enrollment and follow up.)
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00306917
First received: March 23, 2006
Last updated: December 1, 2011
Last verified: December 2011
History of Changes
  Purpose

Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty


Condition Intervention Phase
Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Avascular Necrosis
Acute Fracture
 Device: non-coated femoral hip stem
Device: coated femoral hip stem
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Harris Hip Score (HHS) [ Time Frame: Preoperative, 6, 12, 24, 36, 48, and 60 months ] [ Designated as safety issue: No ]
    The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.


Secondary Outcome Measures:
  • Medical Imaging [ Time Frame: postoperative, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]

Enrollment: 245
Study Start Date: November 2002
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
DuoFix HA
 Device: non-coated femoral hip stem
total hip replacement
Other Name: Summit DuoFix HA hip stem
Active Comparator: 2
Porocoat porous coated
 Device: coated femoral hip stem
total hip replacement
Other Name: Summit Porocoated porous coated hip stem.

Detailed Description:

Hydroxyapatite (HA) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. The purpose of this study is to compare an HA coated and uncoated prosthesis.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary total hip replacement
  • Patient age less than or equal to 75
  • Sufficient bone stock to support prosthesis

Exclusion Criteria:

  • Previous hip replacement
  • Significant angular/bony deformity
  • Active joint sepsis
  • Metal allergy
  • Renal transplant
  • Psychosocial disease
  • Neurological disease/musculoskeletal disease that may affect weight-bearing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306917

Locations
United States, Indiana
DePuy Orthopaedics
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Principal Investigator: David A Fisher, MD Orthopaedics Indianapolis
Principal Investigator: J W Mesko, MD Michigan Orthopaedics Center
Principal Investigator: Paul Perona, MD St Margaret's Hospital Family Orthopaedics
Principal Investigator: Stephan B Lowe, MD Orthopaedic Specialists of the Carolinas
Principal Investigator: Donald L Pomeroy, MD Pomeroy & Reddy
Principal Investigator: Nithin Reddy, MD Pomeroy & Reddy
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00306917     History of Changes
Other Study ID Numbers: SPD
Study First Received: March 23, 2006
Results First Received: January 29, 2010
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Orthopaedics:
Total Hip Replacement

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on May 19, 2013